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Medial Patellofemoral Ligament Reconstruction for Knee Dislocation (SHYFT Trial)

N/A

Recruiting

Led By Laurie A Hiemstra, MD, PhD

Research Sponsored by Banff Sport Medicine Foundation

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Be younger than 65 years old

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 6-, 12- & 24-months post-operative

Awards & highlights

SHYFT Trial Summary

This trial will study the effect of an operation (TTO) on the knee (MPFL-R) to improve outcomes in people with an increased distance between the knee bones.

Who is the study for?

This trial is for young people aged 13-30 with recurrent knee cap dislocation and specific bone alignment issues (TT-TG ≥15mm on MRI or ≥18mm on CT). They must have mature bones, confirmed by x-rays. It's not for those with certain knee ratios, excessive femoral or tibial rotation, severe groove deformities needing surgery, advanced arthritis in the kneecap joint, cartilage restoration procedures, inability to do computer questionnaires or if pregnant.Check my eligibility

What is being tested?

The study tests whether adding a bone realignment procedure (tibial tubercle osteotomy) to a ligament reconstruction surgery improves outcomes in patients with misaligned knees causing instability. This pilot randomized controlled trial will check how feasible it is to recruit participants and follow them up at least one year after surgery.See study design

What are the potential side effects?

Potential side effects may include pain at the surgical site, swelling, infection risk post-surgery, complications from anesthesia during operation and possible need for additional surgeries if there are issues with healing or alignment.

SHYFT Trial Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 6-, 12- & 24-months post-operative

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~6-, 12- & 24-months post-operative

This trial's timeline: 3 weeks for screening, Varies for treatment, and 6-, 12- & 24-months post-operative for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Study Feasibility - follow-up completion

Study Feasibility - patient recruitment

Study Feasibility - protocol adherence

Secondary outcome measures

Banff Patellofemoral Instability Instrument (BPII 2.0)

Complications

Functional Outcomes - Hop Testing

+3 more

SHYFT Trial Design

2Treatment groups

Active Control

Group I: MPFL-RActive Control1 Intervention

Medial patellofemoral ligament reconstruction

Group II: MPFL-R + TTOActive Control1 Intervention

Medial patellofemoral ligament reconstruction with concomitant tibial tubercle osteotomy

Do I qualify?Apply below to find out

Find a Location

Who is running the clinical trial?

ConMed CorporationIndustry Sponsor

8 Previous Clinical Trials

771 Total Patients Enrolled

CONMED CorporationIndustry Sponsor

10 Previous Clinical Trials

1,059 Total Patients Enrolled

1 Trials studying Patellofemoral Dislocation

20 Patients Enrolled for Patellofemoral Dislocation

Banff Sport Medicine FoundationLead Sponsor

3 Previous Clinical Trials

126 Total Patients Enrolled

1 Trials studying Patellofemoral Dislocation

20 Patients Enrolled for Patellofemoral Dislocation

Media Library

Medial patellofemoral ligament reconstruction Clinical Trial Eligibility Overview. Trial Name: NCT05759039 — N/A

Patellofemoral Dislocation Research Study Groups: MPFL-R, MPFL-R + TTO

Patellofemoral Dislocation Clinical Trial 2023: Medial patellofemoral ligament reconstruction Highlights & Side Effects. Trial Name: NCT05759039 — N/A

Medial patellofemoral ligament reconstruction 2023 Treatment Timeline for Medical Study. Trial Name: NCT05759039 — N/A

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Who meets the eligibility requirements to participate in this research program?

"Those with patellofemoral dislocation between the adolesence and early adulthood ages of 13 to 30 are eligible for this clinical trial, which will accept about thirty patients."

Answered by AI

Are individuals aged 20 and over eligible to enroll in the trial?

"To participate in this clinical trial, patients must be aged between 13 and 30. Furthermore, there are 21 trials for minors below the age of 18 and 22 others specifically designed to accomodate elderly subjects above 65 years old."

Answered by AI

Is this research endeavor still accepting new participants?

"The publicly available clinicaltrials.gov database reveals that this trial is not presently seeking patients, even though it was initially posted on May 1st 2023 and its data was last updated February 25th 2023. Fortunately, there are 38 concurrent trials actively recruiting participants right now."

Answered by AI

What is the ultimate goal of this scientific investigation?

"The purpose of this medical trial, to be monitored over a one-year period post-treatment, is to assess the adherence to the protocol. Secondary objectives involve measuring Functional Outcomes such as Limb Symmetry Index on 4 single-leg hop tests (calculated via operative/nonoperative limb percentage score) and Patellar Apprehension Test rating; additionally Complications will be monitored in terms of rates for conditions including infection, blood clots, reduced range of motion, persistent pain, persistent swelling and re-dislocations."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

SHould You transFer the Tubercle?

2023. "SHould You transFer the Tubercle?". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05759039.